UveitisPhase 4NCT00314665
Use of Thalidomide in Chronic Uveitis
A Phase 4 study testing Thalidomide in people with Uveitis, run by University of Cincinnati at 1 site in United States.
Trial summary
This research study is for patients that have been diagnosed with chronic uveitis, a disease that causes inflammation in the eye. Patients are currently being treated with Remicade, Humira, Methotrexate and or similar chemotherapy type drugs to control this inflammation. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Uveitis
- What is being tested?
- Thalidomide
- How many people
- 15 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2004to Aug 2006
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- You are being asked to take part in this research study because you have been diagnosed with chronic uveitis, a disease that causes inflammation in the eye. You are currently being treated with Remicade, Humira, Methotrexate and or similar chemotherapy type drugs to control this inflammation. Despite these medications, you still have inflammation in your eyes. You are being asked to add an additional drug, thalidomide.
Who cannot join
- You will not participate in this research study if any of the following apply to you:
- Pregnant
- If you are a man or woman not willing to take adequate birth control measures comply with FDA-mandated S.T.E.P.S.â program. .
- If you are a breast feeding woman
- If you have a significant peripheral neuropathy (numbness or tingling in your hands or feet)
- Have had a recent blood clot in your leg or lungs
- If you are currently receiving biphosphonates such as zoledronic acid (fosamax)
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Cincinnati Medical Center
Cincinnati, Ohio, 45267-0565
About this study
This research study is for patients that have been diagnosed with chronic uveitis, a disease that causes inflammation in the eye. Patients are currently being treated with Remicade, Humira, Methotrexate and or similar chemotherapy type drugs to control this inflammation. Despite these medications, patients still have inflammation in their eyes. Patients are being asked to add an additional drug, thalidomide.
Read the detailed description
Patients will be in the study for approximately 24 weeks. The visits are at screening, baseline (week 0), and weeks 4,8,12, and 24.
The purpose of this research study is to see if Thalidomide is safe and effective in the treatment of patients with chronic inflammation in their eyes. Thalidomide is approved by the Food and Drug Administration (FDA) for a leprosy skin condition, erythema nodosum leprosum (ENL). The drug works in many different ways, including as an anti-inflammation drug. Therefore, it is thought that this drug might be able to improve symptoms and lung function. At this time, the drug is not approved for use for uveitis.
- Conditions
- Uveitis
- Being tested
- Thalidomide
- Keywords
- Sarcoidosis, Chronic Uveitis, Uveitis, Thalidomide
- Medical subject headings
- Uveitis, Sarcoidosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ThalidomideDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
Need for corticosteroids to control eyes
Global assessment of ocular status
Secondary outcomes (1)
Toxicity
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Apr 2006 (estimated)
- Study startJan 2004
- Study completionAug 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for UveitisStudies of the same condition, open and under way.
- More trials run by University of CincinnatiThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 15 participants
Sponsor and investigators
- Lead sponsor
- University of Cincinnati
- Sponsor type
- University, hospital or other
- Collaborators
- Celgene Corporation
- Investigators
- Robert P Baughman, MD, Principal investigator, Professor of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00314665
- Sponsor's protocol ID
- 03-08-28-05
- Status last verified
- Dec 2007
- First submitted
- 12 Apr 2006
- Last updated
- 6 Dec 2007
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Dec 2007. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Use of Thalidomide in Chronic Uveitis
- ClinicalTrials.gov ID
- NCT00314665
- Acronym / sponsor ID
- 03-08-28-05
- Conditions
- Uveitis
- Keywords
- Sarcoidosis, Chronic Uveitis, Uveitis, Thalidomide
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Terminated
- Enrolment
- 15 participants
- Lead sponsor
- University of CincinnatiUniversity, hospital or other
- Collaborators
- Celgene Corporation
- Study start
- Jan 2004
- Study completion
- Aug 2006 (actual)
- First posted
- 14 Apr 2006 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This research study is for patients that have been diagnosed with chronic uveitis, a disease that causes inflammation in the eye. Patients are currently being treated with Remicade, Humira, Methotrexate and or similar chemotherapy type drugs to control this inflammation. Despite these medications, patients still have inflammation in their eyes. Patients are being asked to add an additional drug, thalidomide.
Detailed description
Patients will be in the study for approximately 24 weeks. The visits are at screening, baseline (week 0), and weeks 4,8,12, and 24.
The purpose of this research study is to see if Thalidomide is safe and effective in the treatment of patients with chronic inflammation in their eyes. Thalidomide is approved by the Food and Drug Administration (FDA) for a leprosy skin condition, erythema nodosum leprosum (ENL). The drug works in many different ways, including as an anti-inflammation drug. Therefore, it is thought that this drug might be able to improve symptoms and lung function. At this time, the drug is not approved for use for uveitis.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- You are being asked to take part in this research study because you have been diagnosed with chronic uveitis, a disease that causes inflammation in the eye. You are currently being treated with Remicade, Humira, Methotrexate and or similar chemotherapy type drugs to control this inflammation. Despite these medications, you still have inflammation in your eyes. You are being asked to add an additional drug, thalidomide.
Key exclusion criteria (7 listed)
- You will not participate in this research study if any of the following apply to you:
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Thalidomide | Drug | – |
Primary outcome
Need for corticosteroids to control eyes
Global assessment of ocular status
1 secondary outcome
Toxicity
Results and safety
The study was stopped early. Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Dec 2007.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Robert P Baughman, MD principal investigator
Professor of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Thalidomide in people with Uveitis, run by University of Cincinnati at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 6 Dec 2007. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early. Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Need for corticosteroids to control eyes. The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Dec 2007.